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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Chin, Internal
510(k) Number K960349
Device Name PERMARIDGE HYDROXYLAPATITE MATRIX
Applicant
CERAMED CORP.
12860 WEST CEDAR DR., STE. 110
LAKEWOOD,  CO  80228
Applicant Contact BARBARA A WATSON
Correspondent
CERAMED CORP.
12860 WEST CEDAR DR., STE. 110
LAKEWOOD,  CO  80228
Correspondent Contact BARBARA A WATSON
Regulation Number878.3550
Classification Product Code
FWP  
Date Received01/25/1996
Decision Date 03/13/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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